TY - JOUR
T1 - Sofosbuvir and velpatasvir for HCV Genotype 2 and 3 infection
AU - Foster, G. R.
AU - Afdhal, N.
AU - Roberts, S. K.
AU - Br, N.
AU - Gane, E. J.
AU - Pianko, S.
AU - Lawitz, E.
AU - Thompson, A.
AU - Shiffman, M. L.
AU - Cooper, C.
AU - Towner, W. J.
AU - Conway, B.
AU - Ruane, P.
AU - Bourlie, M.
AU - Asselah, T.
AU - Berg, T.
AU - Zeuzem, S.
AU - Rosenberg, W.
AU - Agarwal, K.
AU - Stedman, C. A.M.
AU - Mo, H.
AU - Dvory Sobol, H.
AU - Han, L.
AU - Wang, J.
AU - McNally, J.
AU - Osinusi, A.
AU - Brainard, D. M.
AU - McHutchison, J. G.
AU - Mazzotta, F.
AU - Tran, T. T.
AU - Gordon, S. C.
AU - Patel, K.
AU - Reau, N.
AU - Mangia, A.
AU - Sulkowski, M.
N1 - Publisher Copyright:
Copyright © 2015 Massachusetts Medical Society.
PY - 2015/12/31
Y1 - 2015/12/31
N2 - BACKGROUND In phase 2 trials, treatment with the combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir resulted in high rates of sustained virologic response in patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3. METHODS We conducted two randomized, phase 3, open-label studies involving patients who had received previous treatment for HCV genotype 2 or 3 and those who had not received such treatment, including patients with compensated cirrhosis. In one trial, patients with HCV genotype 2 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir, in a once-daily, fixed-dose combination tablet (134 patients), or sofosbuvir plus weight-based ribavirin (132 patients) for 12 weeks. In a second trial, patients with HCV genotype 3 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir for 12 weeks (277 patients) or sofosbuvir-ribavirin for 24 weeks (275 patients). The primary end point for the two trials was a sustained virologic response at 12 weeks after the end of therapy. RESULTS Among patients with HCV genotype 2, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 99% (95% confidence interval [CI], 96 to 100), which was superior to the rate of 94% (95% CI, 88 to 97) in the sofosbuvir-ribavirin group (P = 0.02). Among patients with HCV genotype 3, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 95% (95% CI, 92 to 98), which was superior to the rate of 80% (95% CI, 75 to 85) in the sofosbuvir-ribavirin group (P<0.001). The most common adverse events in the two studies were fatigue, headache, nausea, and insomnia. CONCLUSIONS Among patients with HCV genotype 2 or 3 with or without previous treatment, including those with compensated cirrhosis, 12 weeks of treatment with sofosbuvir- velpatasvir resulted in rates of sustained virologic response that were superior to those with standard treatment with sofosbuvir-ribavirin. (Funded by Gilead Sciences; ASTRAL-2 ClinicalTrials.gov number, NCT02220998; and ASTRAL-3, NCT02201953.)
AB - BACKGROUND In phase 2 trials, treatment with the combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir resulted in high rates of sustained virologic response in patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3. METHODS We conducted two randomized, phase 3, open-label studies involving patients who had received previous treatment for HCV genotype 2 or 3 and those who had not received such treatment, including patients with compensated cirrhosis. In one trial, patients with HCV genotype 2 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir, in a once-daily, fixed-dose combination tablet (134 patients), or sofosbuvir plus weight-based ribavirin (132 patients) for 12 weeks. In a second trial, patients with HCV genotype 3 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir for 12 weeks (277 patients) or sofosbuvir-ribavirin for 24 weeks (275 patients). The primary end point for the two trials was a sustained virologic response at 12 weeks after the end of therapy. RESULTS Among patients with HCV genotype 2, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 99% (95% confidence interval [CI], 96 to 100), which was superior to the rate of 94% (95% CI, 88 to 97) in the sofosbuvir-ribavirin group (P = 0.02). Among patients with HCV genotype 3, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 95% (95% CI, 92 to 98), which was superior to the rate of 80% (95% CI, 75 to 85) in the sofosbuvir-ribavirin group (P<0.001). The most common adverse events in the two studies were fatigue, headache, nausea, and insomnia. CONCLUSIONS Among patients with HCV genotype 2 or 3 with or without previous treatment, including those with compensated cirrhosis, 12 weeks of treatment with sofosbuvir- velpatasvir resulted in rates of sustained virologic response that were superior to those with standard treatment with sofosbuvir-ribavirin. (Funded by Gilead Sciences; ASTRAL-2 ClinicalTrials.gov number, NCT02220998; and ASTRAL-3, NCT02201953.)
UR - http://www.scopus.com/inward/record.url?scp=84952909361&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84952909361&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1512612
DO - 10.1056/NEJMoa1512612
M3 - Article
C2 - 26575258
AN - SCOPUS:84952909361
SN - 0028-4793
VL - 373
SP - 2608
EP - 2617
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 27
ER -